"Start a Line and Get Me a Consent Waiver, STAT!"
Autonomy, Community Consultation, and Informed Consent
in Emergency Research

Peter Steeves
DePaul University

 

Let's say that it's a few years before the turn of the millennium--sometime in the mid-1990s--and you and your spouse are traveling to Houston to visit friends. There is a terrible car accident and both of you are injured badly. Your heads are thrashed about identically. You are both identically wounded and identically unconscious. After a brief ambulance ride you are wheeled into the ER. You cannot see it, but nurses and doctors begin attending to you immediately. One of the doctors disappears behind a curtain; and if you were awake you would be able to make out his silhouette, a shadow surrounded by bustling bodies, flipping a coin, twice. When he emerges, he is carrying with him cooling blankets. He packs them around your spouse's head and body in an attempt to induce hypothermia. Your spouse's body temperature drops nearly eight degrees. There are no blankets for you. You will receive the standard treatment, for perhaps lowering the body temperature of a severe head trauma patient can reduce both morbidity and mortality, or perhaps it will only complicate matters. No one knows. That's why the doctors are experimenting on you and your spouse.

Let's say that I tell you this, tell you that this is perfectly legal and not out of the ordinary, tell you that you and your loved ones can be experimented on in emergency rooms across the country and there is nothing that you, individually, can do about it. I tell you this, and in shock and disbelief you clutch your chest and suffer a heart attack on the spot. Depending on where you live, when the paramedics arrive they might begin CPR, standard manual CPR, or they might try some new device on you, maybe a pneumatically inflated vest or some type of plunger that pumps your heart as if it's a clogged toilet. Of course, no one knows how well such technologies work. Or don't work. That's why the doctors are experimenting on you.

With regulation changes at the federal level over the last few years, Emergency research has been given the green light even in cases where there is no informed consent. The practice is controversial. But even more controversial are the suggestions for securing "community consent" rather than individual consent prior to local ERs undertaking a research program. How does one define "community", religiously, culturally, geographically, etc.? And under what circumstances should the collective be allowed to be the keepers of the individual's fate?

In this paper I trace the history of informed consent debates in general, with special attention being given to questions of how to do medical research on unconscious ER patients. Arguing that autonomy is not an absolute value that trumps all others, I suggest a new phenomenological foundation to the doctor-patient relationship, ultimately proposing a communitarian answer to the ethical dilemmas raised by the waiver of informed consent. Operating both at the philosophical/theoretical/ethical level and the pragmatic/practical level, I sketch out a plan for a new dual IRB/CRB system, one half of which consists of a traditional Institutional Review Board of medical specialists evaluating research proposals, the other half functioning as a Community Review Board at the local level. By rethinking our conception of individual rights, and by acting as a true community, perhaps we can get past naive worries about autonomy, and move on to improving our institutions, our communities, and our lives, envisioning a collective future, then, where improvement is measured by a health care system that is both more efficacious and more ethical.

 

PDF of Article